MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. SUNSTAR GUM PERIOSHIELD ORAL HEALTH RINSE; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)

Lot Number 02A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ulcer (2274); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Ulcers formed under my tongue, to the point where i was unable to move my tongue around.My gums were irritated and severely swollen.This lasted about three days in total.

• Brand Name: SUNSTAR GUM PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12058134
• MDR Text Key: 258625659
• Report Number: MW5102096
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2023
• Device Lot Number: 02A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability